Inhaled glucocorticosteroids have now become first-line therapy for the treatment of chronic asthma in many countries. They are the most effective asthma therapy currently available, and numerous studies have documented their long-term efficacy in asthma control in adults and in children. Inhaled steroids suppress inflammation in asthmatic airways, although their precise molecular mechanism of action is not yet certain. It is likely that steroids affect the transcription of several steroid-responsive genes, and, of particular importance, they may inhibit cytokine gene transcription and cytokine effects, thereby reducing the chronic inflammation in asthmatic airways. Inhaled steroids are now used at a much earlier stage in asthma therapy, and there is a strong argument for their early introduction in both adults and children to prevent asthma morbidity and mortality and possibly the structural changes resulting from uncontrolled chronic inflammation, which may lead to irreversible airflow obstruction in some patients. Of paramount importance is the question of safety as inhaled steroids are likely to be required for a long time. Local side effects caused by oropharyngeal deposition of the inhaled steroid may be reduced by the use of spacer devices and mouthwashing. Systemic side effects caused by gastrointestinal absorption of the fraction deposited in the oropharynx may also be reduced by these devices. There are differences in the systemic bioavailability of the different inhaled steroids currently in use, and inhaled steroids with the lowest bioavailability should be chosen when high doses of inhaled steroids are required for asthma control. Systemic side effects are usually observed only when daily doses of > 800 micrograms are inhaled, and whether effects on very sensitive biochemical indices are relevant to long-term deleterious effects is not yet certain. There is now overwhelming evidence that the doses of inhaled steroids required to control asthma in the majority of adults and children are safe and without systemic side effects. It is important to control asthma with the minimum dose of inhaled steroids possible, however. In the future it may be possible to develop inhaled steroids with even fewer systemic effects if the fraction absorbed from the respiratory tract can be rapidly metabolized in the bloodstream.

Efficacy and safety of inhaled corticosteroids in asthma. Report of a workshop held in Eze, France, October 1992.

Background Systemic corticosteroid therapy is central to the management of acute asthma. The use of inhaled corticosteroids (ICS) may also be beneficial in this setting. Objectives To determine the benefit of ICS for the treatment of patients with acute asthma managed in the emergency department (ED). Search methods We identified controlled clinical trials from the Cochrane Airways Group specialised register of controlled trials. Bibliographies from included studies, known reviews, and texts also were searched. The latest search was September 2012. Selection criteria We included randomised controlled trials (RCTs) and quasi-RCTs. Studies were included if patients presented to the ED or its equivalent with acute asthma, and were treated with ICS or placebo, in addition to standard therapy. Two review authors independently selected potentially relevant articles, and then independently selected articles for inclusion. Methodological quality was independently assessed by two review authors. There were three different types of studies that were included in this review: 1) studies comparing ICS vs. placebo, with no systemic corticosteroids given to either treatment group, 2) studies comparing ICS vs. placebo, with systemic corticosteroids given to both treatment groups, and 3) studies comparing ICS alone versus systemic corticosteroids. For the analysis, the first two types of studies were included as separate subgroups in the primary analysis (ICS vs. placebo), while the third type of study was included in the secondary analysis (ICS vs. systemic corticosteroid). Data collection and analysis Data were extracted independently by two review authors if the authors were unable to verify the validity of extracted information. Missing data were obtained from the authors or calculated from other data presented in the paper. Where appropriate, individual and pooled dichotomous outcomes were reported as odds ratios (OR) with 95% confidence intervals (CIs). Where appropriate, individual and pooled continuous outcomes were reported as mean differences (MD) or standardized mean differences (SMD) with 95% CIs. The primary analysis employed a fixed-effect model and a random-effects model was used for sensitivity analysis. Heterogeneity is reported using I-squared (I2) statistics. Main results Twenty trials were selected for inclusion in the primary analysis (13 paediatric, seven adult), with a total number of 1403 patients. Patients treated with ICS were less likely to be admitted to hospital (OR 0.44; 95% CI 0.31 to 0.62; 12 studies; 960 patients) and heterogeneity (I2 = 27%) was modest. This represents a reduction from 32 to 17 hospital admissions per 100 patients treated with ICS in comparison with placebo. Subgroup analysis of hospital admissions based on concomitant systemic corticosteroid use revealed that both subgroups indicated benefit from ICS in reducing hospital admissions (ICS and systemic corticosteroid versus systemic corticosteroid: OR 0.54; 95% CI 0.36 to 0.81; 5 studies; N = 433; ICS versus placebo: OR 0.27; 95% CI 0.14 to 0.52; 7 studies; N = 527). However, there was moderate heterogeneity in the subgroup using ICS in addition to systemic steroids (I2 = 52%). Patients receiving ICS demonstrated small, significant improvements in peak expiratory flow (PEF: MD 7%; 95% CI 3% to 11%) and forced expiratory volume in one second (FEV1: MD 6%; 95% CI 2% to 10%) at three to four hours post treatment). Only a small number of studies reported these outcomes such that they could be included in the meta-analysis and most of the studies in this comparison did not administer systemic corticosteroids to either treatment group. There was no evidence of significant adverse effects from ICS treatment with regard to tremor or nausea and vomiting. In the secondary analysis of studies comparing ICS alone versus systemic corticosteroid alone, heterogeneity among the studies complicated pooling of data or drawing reliable conclusions. Authors' conclusions ICS therapy reduces hospital admissions in patients with acute asthma who are not treated with oral or intravenous corticosteroids. They may also reduce admissions when they are used in addition to systemic corticosteroids; however, the most recent evidence is conflicting. There is insufficient evidence that ICS therapy results in clinically important changes in pulmonary function or clinical scores when used in acute asthma in addition to systemic corticosteroids. Also, there is insufficient evidence that ICS therapy can be used in place of systemic corticosteroid therapy when treating acute asthma. Further research is needed to clarify the most appropriate drug dosage and delivery device, and to define which patients are most likely to benefit from ICS therapy. Use of similar measures and reporting methods of lung function, and a common, validated, clinical score would be helpful in future versions of this meta-analysis.

/pdf/early-use-of-inhaled-corticosteroids-in-the-emergency-43moy065jc.pdf

Early use of inhaled corticosteroids in the emergency department treatment of acute asthma

Taxane-induced nail changes: incidence, clinical presentation and outcome

ContextRelapses of acute asthma following emergency
department (ED) discharge can be reduced with systemic corticosteroid
treatment. However, whether inhaled corticosteroids (ICSs) provide
additional benefit is not known.ObjectiveTo determine whether the addition of ICSs to oral
corticosteroid treatment would reduce relapses in patients with acute
asthma discharged from the ED.Design and SettingPlacebo-controlled, double-blind, randomized
clinical trial conducted in a community teaching hospital ED in Canada
between November 1995 and September 1997, with a 21-day follow-up.ParticipantsA total of 1006 consecutive patients aged 16 to 60
years presented to the ED with acute asthma; after excluding those
using oral and/or inhaled corticosteroids as well as those meeting
other exclusion criteria, 188 were included in the study.InterventionsPatients were discharged with a nontapering course
of oral prednisone (50 mg/d) for 7 days. In a double-blind fashion,
patients were randomly assigned to 1600 µg/d of inhaled budesonide
(n=94) or identical placebo (n=94) for
21 days.Main Outcome MeasuresIncidence of relapse, defined as an
unscheduled visit for worsening asthma symptoms, in budesonide vs
placebo groups. Secondary outcomes included response to the Asthma
Quality of Life Questionnaire, β2-agonist use, symptom
score, global asthma improvement assessment, and pulmonary function.ResultsFive patients in the budesonide group and 3 in the placebo
group either dropped out or were lost to follow-up but were included in
primary analyses. After 21 days, 12 (12.8%) of 94 patients in the
budesonide group experienced a relapse compared with 23 (24.5%) of 94
in the placebo group, a 48% relapse reduction
(P=.049). Asthma Quality of Life Questionnaire
scores were higher (better quality) in the budesonide group
(P=.001), as well as for all domain scores
(P=.001 to .01). Fewer
β2-agonist activations were used at the end of the trial
by patients receiving budesonide (2.4/d vs 4.2/d;
P=.01). Symptom scores
(P=.001 to .004) and self-assessed asthma
improvement scores (based on a 7-point Likert scale) (6.2 vs 5.2;
P<.001) were higher (indicating fewer symptoms) for
budesonide vs placebo. There were no differences in pulmonary function
between the groups (peak expiratory flow rate: budesonide, 437 vs
placebo, 453 L/min; P=.39) at 21 days. Using
this approach, as few as 9 patients would require budesonide to prevent
1 relapse.ConclusionsPatients discharged from the ED following treatment
for acute asthma benefit from added treatment with high-dose inhaled
budesonide for 21 days compared with oral corticosteroids
alone.

https://jamanetwork.com/journals/jama/articlepdf/190232/jce90023.pdf

Inhaled budesonide in addition to oral corticosteroids to prevent asthma relapse following discharge from the emergency department: a randomized controlled trial.

Chemotherapy for advanced non-small-cell lung cancer.

In a multicenter, randomized, double-blind study, inhaled beclomethasone dipropionate (BDP) 1,500 µg/day was compared to placebo in 43 chronic asthmatic patients uncontrolled by inhaled salbutamol and oral theophylline. During the prestudy period, a test of maximal steroid reversibility with oral prednisolone 0.5 mg/kg/day for 14 days was performed. The therapeutic response was measured over an 8-wk period as the ability to maintain the clinical improvement and the optimal pulmonary function induced by prednisolone. During the study, severe asthma exacerbation occurred in one (5%) of the 21 patients who received BDP and in 15 (78%) of the 22 patients who received placebo (p < 0.001). In patients who received BDP, FEV1 and peak expiratory flow (PEF) remained above the optimal postprednisolone value, with a trend to improvement during the 8-wk study period. In patients who received placebo, FEV1 and PEF decreased and remained below the optimal value. We conclude that, in chronic asthma, inhaled BDP 1,500 µg...

High Doses of Inhaled Corticosteroids in Unstable Chronic Asthma: A Multicenter, Double-blind, Placebo-controlled Study

The purpose is to determine the response to, and toxicity of docetaxel (Taxotere) in patients with inoperable non small cell lung cancer (NSCLC), previously untreated. Seventy patients with stage IIIB or IV NSCLC were treated by 100 mg/m2/ 3 weeks of docetaxel until tumor progression or severe toxicity. Premedication with diosmine and prednisolone was given in all patients: 66/70 were eligible and 55/70 were assessable for antitumoral activity. Median age: 63 years, WHO performans status 0-1: 83%, stage IV: 96%. For eligible patients, 17/66 (26%) achieved an objective response: 1 complete response and 16 partial response (IC 95% = 15-36). With a median follow-up of 23.4 months (range 14.9-28.7), for evaluable patients, the median response duration was 8 months, the median time to progression 4 months, and the median survival time 10 months. The median number of administered cycles is 5 (range 1-12). The estimate one year survival rate was 47%. Seventy-six patients presented neutropenia (grade 3-4); febrile neutropenia was observed in 7% of cycles. Non haematological toxicities are: fluid retention related to docetaxel (2.9%), diarrhea (6%), nausea-vomiting (4%), asthenia (3%), nail changes (6%). Docetaxel (Taxotere) administered at 100 mg/m2/3 weeks has relevant clinical activity in previously untreated NSCLC with a acceptable toxicity.

Phase II study of docetaxel in inoperable advanced non small cell lung cancer

Cisplatin-mitomycin and vindesine in the treatment of inoperable non-small cell lung cancer groupe français de pneumo-cancérologie (GFPC)

UNLABELLED Between February 1992 and May 1993, 22 patients older than 75 years, with non small cell lung cancer, were treated with carboplatin and oral etoposide. There were 18 men and four women with a median age of 79 years. Fourteen patients had an epidermoid carcinoma: four had an adenocarcinoma and four had an undifferentiated carcinoma. Carboplatin was administered intravenously on day 1 at a dose of 300 mg/m2; oral etoposide was administered at a dose of 600 mg/m2 (two capsules daily) for 9, 10, 11, or 12 days according to body surface. Courses were repeated every 28 days for a total of three courses. TOXICITY 15 patients (68%) had received previous chemotherapy. Myelosuppression was the main problem with one grade IV and five grade III hematologic toxicities. We observed one mild neurologic toxicity. RESULTS 19 patients were evaluable for response. We observed one complete response (5%), five disease stabilizations (26%) and 13 disease progressions. Median survival was 5 months. These results led to discontinue this study.

[Carboplatin-VP16 combination in non small cell lung cancers in the aged patient. A study of the French group in pneumology (GFPC)].

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High Doses of Inhaled Corticosteroids in Unstable Chronic Asthma: A Multicenter, Double-blind, Placebo-controlled Study

Phase II study of docetaxel in inoperable advanced non small cell lung cancer

Cisplatin-mitomycin and vindesine in the treatment of inoperable non-small cell lung cancer groupe français de pneumo-cancérologie (GFPC)

[Carboplatin-VP16 combination in non small cell lung cancers in the aged patient. A study of the French group in pneumology (GFPC)].